Remote Delivery of a Mindfulness-based Intervention for Tics (MBIT)

Johns Hopkins University

Status: Enrolling

Conditions: Persistent Motor Tic Disorder; Chronic Motor Tic Disorder; Tourette Syndrome; Persistent Vocal Tic Disorder; Chronic Vocal Tic Disorder; Persistent Tic Disorder; Tourette's Disorder; Tic Disorders

Treatments: Other: psychoeducation with relaxation and supportive therapy (PRST); Other: mindfulness-based intervention for tics (MBIT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06408662

R01AT012455 (U.S. NIH Grant/Contract)

IRB00413599

Details and patient eligibility

About

This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.

Full description

Tourette's syndrome and other persistent tic disorders (collectively, TS) is a condition that onsets in childhood and affects ~1% of the population. Alongside motor and vocal tics, patients with TS experience distressing somatosensory sensations (i.e., premonitory urges) and co-occurring mental health conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and ADHD. Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains (e.g., physical, social, academic, occupational, emotional, and familial). Two evidence-based treatments exist for TS: behavior therapy and pharmacotherapy. Behavior therapy [often referred to as habit reversal training (HRT) or the comprehensive behavioral intervention for tics (CBIT)] is an evidence-based treatment that has been shown to reduce the severity of tic symptoms, and has a low risk for adverse effects. Although behavior therapy is recognized as a first-line intervention for TS, less than 40% of adults with TS respond to this evidence-based treatment. Additionally, current behavioral interventions are often inaccessible for adults with TS. While pharmacotherapy for tic management (e.g., antipsychotic medications) has been shown to be effective, these treatments can have adverse side effects with detrimental health consequences. Thus, there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity, beneficial for co-occurring conditions, and have few adverse health effects. Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions. Based on the investigator's prior work, the investigators believe that a mindfulness-based intervention for tics (MBIT) is beneficial for adults with TS.

This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods. The investigators will test the mechanisms by which MBIT reduces tic severity, and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards "treating the whole person". Finally, the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. be ≥18 years of age;
2. meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview;
3. have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of >14 (when motor and vocal tics are present) or >10 (when only motor or vocal tics are present);
4. be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;
5. be not engaged in psychotherapy for non-TS conditions and/or be on a stable course of therapy for 6 months prior to study participation
6. be fluent in English;
7. have access to a smart phone and/or tablet.

Exclusion criteria

1. a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;
2. severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;
3. concurrent psychotherapy for TS;
4. prior extensive experience with mindfulness and/or meditation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

mindfulness-based intervention for tics (MBIT)

Experimental group

Description:

This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework).

Treatment:

Other: mindfulness-based intervention for tics (MBIT)

psychoeducation with relaxation and supportive therapy (PRST)

Active Comparator group

Description:

This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework).

Treatment:

Other: psychoeducation with relaxation and supportive therapy (PRST)